Systems and methods for activating and controlling impedance-based detection systems of implantable medical devices

• US 8,295,918 B2
• Filed: 02/25/2011
• Issued: 10/23/2012
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Rosenberg, Stuart, Nabutovsky, Yelena, Wenzel, Brian J., Gill, Jong, Hsu, William, Xi, Cecilia Q.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/035,773
• Publication Number:
  US 20120221066A1
• Time in Patent Office: 606 Days
• Field of Search: 600/509
• US Class Current: 600/509
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Techniques are provided for use with implantable medical devices for addressing encapsulation effects, particularly in the detection of cardiac decompensation events such as heart failure (HF) or cardiogenic pulmonary edema (PE.) In one example, during an acute interval following device implant, cardiac decompensation is detected using heart rate variability (HRV), ventricular evoked response (ER) or various other non-impedance-based parameters that are insensitive to component encapsulation effects. During the subsequent chronic interval, decompensation is detected using intracardiac or transthoracic impedance signals. In another example, the degree of maturation of encapsulation of implanted components is assessed using impedance frequency-response measurements or based on the frequency bandwidth of heart sounds or other physiological signals. In this manner, impedance-based HF/PE detection systems can be activated as soon as component encapsulation has matured, without necessarily waiting until completion of a preset post-implant maturation interval, often set to forty-five days or more.

Claims

1. A method for use with an implantable medical device for implant within a patient, the method comprising:

during an acute interval following device implant;

detecting a possible cardiac decompensation event within the patient using at least one detection parameter that is relatively insensitive to component encapsulation effects; and

following the acute interval, detecting possible cardiac decompensation using at least one detection parameter that is relatively more sensitive to component encapsulation effects.

2. The method of claim 1 wherein the cardiac decompensation event includes one or more of heart failure (HF), congestive heart failure (CHF) and cardiogenic pulmonary edema (PE).

3. The method of claim 1 wherein detecting a possible cardiac decompensation event during the acute interval includes:

sensing non-impedance-based cardiac decompensation detection parameters during the acute interval that are relatively insensitive to component encapsulation effects as compared to impedance-based detection parameters; and

detecting the possible cardiac decompensation event during the acute interval using the non-impedance-based detection parameters.

4. The method of claim 3 wherein the non-impedance-based detection parameters include one or more of heart rate variability (HRV) parameters, ventricular evoked response (ER) parameters, atrioventricular (AV) delay parameters and interventricular (VV) delay parameters.

5. The method of claim 4 wherein the non-impedance-based detection parameters are supplemented using one or more of patient posture signals, patient activity signals and blood pressure signals.

6. The method of claim 4 wherein the ventricular ER parameters include one or more of a peak-to-peak ventricular ER amplitude parameter, a paced depolarization integral (PDI) parameter, and an ER T-wave minimum parameter.

7. The method of claim 4 wherein the AV delay parameters include one or more of a sensed AV delay, a paced AV delay, and the temporal variability of sensed and/or paced AV delay.

8. The method of claim 4 wherein the VV delay parameters include one or more of an LV-paced RV sense delay and an RV-paced LV sense delay.

9. The method of claim 1 wherein detecting a possible cardiac decompensation event following the acute interval includes:

sensing impedance-based cardiac decompensation detection parameters following the acute interval that are relatively more sensitive to component encapsulation effects as compared to non-impedance-based detection parameters; and

detecting the possible cardiac decompensation event following the acute interval using the impedance-based detection parameters.

10. The method of claim 9 wherein the impedance-based detection parameters include one or more of transthoracic impedance and intracardiac impedance using electrodes implanted within patient tissue.

11. The method of claim 9 further including:

detecting the end of the acute interval; and

switching from the non-impedance-based detection parameters to the impedance-based detection parameters upon detection of the end of the acute interval.

12. The method of claim 11 wherein the acute interval is deemed to end a predetermined number of days after implant.

13. The method of claim 11 wherein switching to the impedance-based detection parameters upon detection of the end of the acute interval is performed gradually.

14. The method of claim 11 wherein switching to the impedance-based detection parameters is performed substantially immediately.

15. The method of claim 11 wherein detecting the end of the acute interval includes:

detecting impedance-based detection parameters to detect when impedance signals satisfy a predetermined stability criteria indicative of the end of the acute interval.

16. The method of claim 11 wherein detecting the end of the acute interval includes:

detecting and examining non-impedance parameters to confirm an indication of signal stability.

17. The method of claim 9 wherein, following the acute interval, cardiac decompensation is detected using a combination of both impedance-based detection parameters and non-impedance-based detection parameters.

18. The method of claim 1 wherein, following the acute interval, cardiac decompensation is detected by applying a moving average window to detection parameters and wherein the duration of the moving average window increases with time until reaching a preferred duration.

19. A system for use with an implantable medical device for implant within a patient, the system comprising:

an acute interval cardiac decompensation detection system operative during an acute interval following device implant to detect a possible cardiac decompensation event within the patient using one or more detection parameters that are relatively insensitive to component encapsulation effects; and

a chronic interval cardiac decompensation detection system operative following the acute interval to detect a possible cardiac decompensation event within the patient using one or more detection parameters that are relatively more sensitive to component encapsulation effects.

20. A system for use with an implantable medical device for implant within a patient, the system comprising:

means, operative during an acute interval following device implant, for detecting a possible cardiac decompensation event within the patient using one or more detection parameters that are relatively insensitive to component encapsulation effects; and

means, operative following the acute interval, for detecting a possible cardiac decompensation event within the patient using one or more detection parameters that are relatively more sensitive to component encapsulation effects.